Generic Name and Formulations:
Codeine phosphate 30mg, butalbital 50mg, aspirin 325mg, caffeine 40mg; caps.

Company:
Actavis
Indications for FIORINAL w. CODEINE:
Tension (or muscle contraction) headache.

Adult Dose for FIORINAL w. CODEINE:
1–2 tabs or caps every 4 hours, as needed; max 6/day.

Children's Dose for FIORINAL w. CODEINE:
Not recommended.

See Also:
FIORINAL

Pharmacological Class:
Opioid + barbiturate + salicylate.

Contraindications:
Aspirin or NSAID allergy. Porphyria. Hemorrhagic diathesis. Peptic ulcer or other serious GI lesions. Also with Codeine: post-op pain management in children who have undergone tonsillectomy and/or adenoidectomy.

Warnings/Precautions:
Drug abusers. Impaired hepatic or renal function (monitor). Depression. Suicidal tendencies. Asthma. Bleeding disorders. Underlying hemostatic defects. Varicella or influenza in children or teenagers. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended. Also with Codeine: risk of respiratory depression and death related to ultra-rapid metabolizers of codeine (esp. in children in post-op tonsillectomy and/or adenoidectomy). Obstructive sleep apnea. Head injury. Increased intracranial pressure. Acute abdomen. Impaired thyroid or adrenocortical function. Addison's disease. GI or GU obstruction.

Interactions:
Potentiation with alcohol, general anesthetics, tranquilizers, other CNS depressants, anticoagulants, hypoglycemics, insulin, plasma protein bound drugs, MAOIs, tricyclic antidepressants, anticholinergics. Concomitant NSAIDs increase risk of GI bleeding. May antagonize uricosurics, oral anticoagulants, antibiotics, corticosteroids. Induction of drug-metabolizing hepatic enzymes. Increased levels of 6-mercaptopurine, methotrexate.

Adverse Reactions:
Drowsiness, dizziness, sedation, intoxicated feeling, nausea, vomiting, difficulty swallowing, heartburn, abdominal pain, depression, prolonged bleeding time, paradoxical excitement, constipation, abuse potential, skin reactions, anaphylaxis; overdosage: respiratory depression, salicylism.

How Supplied:
Caps—100, 500; W. Codeine—100